Associate Director, Biostatistics Consultant – Oncology

🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

⏳ Contract/Temporary

🟠 Senior

👔 Director

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ClinChoice

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1998

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ClinChoice is a global full-service contract research organization (CRO) established in 1995, specializing in clinical development, post-marketing, and functional service support for the pharmaceutical, biotechnology, and medical devices industries. They provide comprehensive solutions from early clinical development to post-approval lifecycle management, with expertise in a variety of therapeutic areas such as autoimmune and inflammation, dermatology, endocrinology, infectious diseases, neuroscience, and oncology. ClinChoice aims to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. The company supports its clients with clinical, regulatory, and operational expertise across all phases of product development.

📋 Description

• Provide strategic statistical leadership across development programs • Work closely with Clinical Development, Regulatory, Medical, Commercial, and Portfolio teams • Select superiority, non-inferiority, or equivalence-based trial types • Define and validate primary and secondary oncology endpoints • Design adaptive trials, including seamless Phase II/III, group sequential, basket, and umbrella trials • Perform sample size, power, and subgroup powering calculations • Establish go/no-go decision gates, proof-of-concept criteria, and futility stopping rules • Prepare and review data packages and attend health authority meetings to defend trial designs, endpoints, and statistical analysis plans • Anticipate and address regulatory objections involving missing data, multiplicity adjustments, and bias • Use historical benchmark data and simulation models to estimate Probability of Technical Success • Support pipeline prioritization decisions regarding advancing, partnering, or discontinuing assets

🎯 Requirements

• Master's or Ph.D. in Statistics, Biostatistics, or a related quantitative discipline • Significant experience in pharmaceutical, biotechnology, or CRO environments with strong oncology experience • Demonstrated experience in strategic drug development and clinical trial design beyond traditional study-level responsibilities • Strong knowledge of oncology endpoints, adaptive designs, sample size/power, simulations, and statistical methodology • Experience supporting regulatory submissions and health authority interactions • Excellent communication and leadership skills with the ability to influence senior cross-functional stakeholders

🏖️ Benefits

• Security and additional career opportunities of working for a global CRO • Continuous training and close management to develop and maintain highly-qualified personnel • Equal opportunity employer committed to diversity and inclusivity